HIV InfectionsPhase 1NCT01001247
TMC278-TiDP6-C154: Evaluation of the Possible Influence of Omeprazole Intake - and the pH Increase in the Stomach Triggered by Omeprazole Intake - on the Blood Levels of TMC278 in Healthy Volunteers
A Phase 1 study testing TMC278; Omeprazole in people with HIV Infections, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
The purpose of this study is to investigate the extent by which intake of 20 mg once daily (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d.. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- TMC278; Omeprazole
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day (or non-smoking) for at least 3 months prior to selection
- Weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form (ICF) signed voluntarily
- Able to comply with protocol requirements
- Healthy on the basis of a pretrial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs, and a 12-lead electrocardiogram (ECG)
Who cannot join
- No positive testing for HIV-1 or -2
- females, except if menopausal for at least 2 years, or with total hysterectomy or bilateral tubal ligation (without repair surgery)
- No infection of Hepatitis A, B or C
- No currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
- No history of clinically relevant heart rhythm disturbances
- No positive urine drug testing
About this study
Official title: A Phase I, Open Label, Randomized, 4-way Crossover Trial to Evaluate the Pharmacokinetics of TMC278 25mg and 50mg in the Presence of Omeprazole 20mg q.d., in Healthy Subjects
The purpose of this study is to investigate the extent by which intake of 20 mg once daily (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d.. This study also investigates - in case levels of TMC278 are reduced when co-administered with omeprazole - whether a double dose of TMC278 (50 mg q.d.) or a separation of intake of both drugs by 12 hours may circumvent a decrease of TMC278 levels in the blood below the clinical effective concentration. Omeprazole is prescribed to reduce the production of gastric acid. Since TMC278 requires gastric acid to be properly dissolved and taken up in the blood circulation, intake of omeprazole has an influence on the levels of TMC278 in the blood circulation. This effect has been revealed in a previously conducted clinical trial, using the combination of 150 mg TMC278 q.d. and 20 mg q.d. omeprazole. The currently proposed study will also further explore the relationship between the levels of TMC278 in the blood at several time points and the acidity of the stomach. Also the short-term safety and tolerability of co-administration of omeprazole 20 mg q.d. and TMC278 25 mg q.d. will be assessed.
Read the detailed description
This is an open label study, which means that all parties including the study doctor, the healthy volunteer and the sponsor plus his designees will know at all times which treatment the volunteer is in. This is a 4-way cross over trial, which means that every volunteer will be sequentially subjected to 4 different treatments.There are 4 treatment sequences defined: ABCD, BDAC, CADB and DCBA. Treatment sessions are organized in such a way that between successive intakes of TMC278 a period of 14 days is respected. Treatment A is the reference, showing the levels of TMC278 in blood without any intake of omeprazole. These data points will be compared with blood levels of TMC278 when TMC278 is being administered 1.5 hours after intake of omeprazole (Treatment B) or with blood levels of TMC278 when being administered 12 hours after intake of omeprazole (Treatment C). Treatment B will be the comparator of Treatment D, in order to reveal whether doubling the dose of TMC278 (50 mg q.d. used in Treatment D) can circumvent the reduction of TMC278 levels when being co-administered with omeprazole, if applicable. In each session, an extensive investigation of the levels of TMC278 in the blood circulation is planned. Levels of TMC278 will be assessed at 16 different time points, i.e. before administration of TMC278, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours after intake of TMC278. During all treatments, the acidity in the stomach (called intragastric pH) will be monitored during a 24-hour period on the day of TMC278 intake. Standard Safety assessments (blood biochemistry and haematology, urine analysis, ECG, pulse rate and blood pressure) will be performed on Day1, 2 and 8 in Treatment A and on Day-5, 1, 2, 8 in Treatment B, C and D. Treatment A: 25mg TMC278 in the morning of Day1; Treatment B: 25mg TMC278 in the morning of Day1 and 20mg omeprazole in the morning from Day-5 through Day2 (7 days in total); Treatment C: same as treatment B, but omeprazole is taken in the evening; Treatment D: same as treatment B, but 50mg omeprazole is taken instead of 25mg. All intakes are oral. In Treatment B, C and D, the intake of omeprazole is witnessed by site staff on Days -5, -3, -2 and -1
- Conditions
- HIV Infections
- Being tested
- TMC278; Omeprazole
- Keywords
- TMC278-TiDP6-C154, TMC278-C154, TMC278, Healthy volunteers, omeprazole, proton pump inhibitor, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC278; OmeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of TMC278 assessed after co-administration of 20mg q.d. omeprazole taken either in the morning (1.5 h before TMC278) or in the evening (12 h before TMC278); assess 24h intragastric pH at days of intake of TMC278
Measured: Plasma levels: Treatment A, B, C and D: Day1 (at 11 time points), Day2, 3, 4, 6 and 8 (all at 1 time point). Intragastric pH: Treatment A, B, C and D at Day1 (=day of intake TMC278).
Secondary outcomes (1)
To evaluate the short-term safety and tolerability of co-administration of omeprazole with a single 25mg and 50mg dose of TMC278
Measured: 13 weeks (this includes a treatment, washout and follow up period and is excluding screening period of maximum 21 days before first medication intake)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tibotec Pharmaceuticals Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001247
- Sponsor's protocol ID
- CR016267
- Status last verified
- Jul 2010
- First submitted
- 23 Oct 2009
- Last updated
- 9 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Randomized, 4-way Crossover Trial to Evaluate the Pharmacokinetics of TMC278 25mg and 50mg in the Presence of Omeprazole 20mg q.d., in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01001247
- Acronym / sponsor ID
- CR016267
- Conditions
- HIV Infections
- Keywords
- TMC278-TiDP6-C154, TMC278-C154, TMC278, Healthy volunteers, omeprazole, proton pump inhibitor, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the extent by which intake of 20 mg once daily (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d.. This study also investigates - in case levels of TMC278 are reduced when co-administered with omeprazole - whether a double dose of TMC278 (50 mg q.d.) or a separation of intake of both drugs by 12 hours may circumvent a decrease of TMC278 levels in the blood below the clinical effective concentration. Omeprazole is prescribed to reduce the production of gastric acid. Since TMC278 requires gastric acid to be properly dissolved and taken up in the blood circulation, intake of omeprazole has an influence on the levels of TMC278 in the blood circulation. This effect has been revealed in a previously conducted clinical trial, using the combination of 150 mg TMC278 q.d. and 20 mg q.d. omeprazole. The currently proposed study will also further explore the relationship between the levels of TMC278 in the blood at several time points and the acidity of the stomach. Also the short-term safety and tolerability of co-administration of omeprazole 20 mg q.d. and TMC278 25 mg q.d. will be assessed.
Detailed description
This is an open label study, which means that all parties including the study doctor, the healthy volunteer and the sponsor plus his designees will know at all times which treatment the volunteer is in. This is a 4-way cross over trial, which means that every volunteer will be sequentially subjected to 4 different treatments.There are 4 treatment sequences defined: ABCD, BDAC, CADB and DCBA. Treatment sessions are organized in such a way that between successive intakes of TMC278 a period of 14 days is respected. Treatment A is the reference, showing the levels of TMC278 in blood without any intake of omeprazole. These data points will be compared with blood levels of TMC278 when TMC278 is being administered 1.5 hours after intake of omeprazole (Treatment B) or with blood levels of TMC278 when being administered 12 hours after intake of omeprazole (Treatment C). Treatment B will be the comparator of Treatment D, in order to reveal whether doubling the dose of TMC278 (50 mg q.d. used in Treatment D) can circumvent the reduction of TMC278 levels when being co-administered with omeprazole, if applicable. In each session, an extensive investigation of the levels of TMC278 in the blood circulation is planned. Levels of TMC278 will be assessed at 16 different time points, i.e. before administration of TMC278, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours after intake of TMC278. During all treatments, the acidity in the stomach (called intragastric pH) will be monitored during a 24-hour period on the day of TMC278 intake. Standard Safety assessments (blood biochemistry and haematology, urine analysis, ECG, pulse rate and blood pressure) will be performed on Day1, 2 and 8 in Treatment A and on Day-5, 1, 2, 8 in Treatment B, C and D. Treatment A: 25mg TMC278 in the morning of Day1; Treatment B: 25mg TMC278 in the morning of Day1 and 20mg omeprazole in the morning from Day-5 through Day2 (7 days in total); Treatment C: same as treatment B, but omeprazole is taken in the evening; Treatment D: same as treatment B, but 50mg omeprazole is taken instead of 25mg. All intakes are oral. In Treatment B, C and D, the intake of omeprazole is witnessed by site staff on Days -5, -3, -2 and -1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day (or non-smoking) for at least 3 months prior to selection
- Weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form (ICF) signed voluntarily
- Able to comply with protocol requirements
- Healthy on the basis of a pretrial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs, and a 12-lead electrocardiogram (ECG)
Key exclusion criteria (6 listed)
- No positive testing for HIV-1 or -2
- females, except if menopausal for at least 2 years, or with total hysterectomy or bilateral tubal ligation (without repair surgery)
- No infection of Hepatitis A, B or C
- No currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
- No history of clinically relevant heart rhythm disturbances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMC278; Omeprazole | Drug | – |
Primary outcome
Plasma levels of TMC278 assessed after co-administration of 20mg q.d. omeprazole taken either in the morning (1.5 h before TMC278) or in the evening (12 h before TMC278); assess 24h intragastric pH at days of intake of TMC278
Time frame: Plasma levels: Treatment A, B, C and D: Day1 (at 11 time points), Day2, 3, 4, 6 and 8 (all at 1 time point). Intragastric pH: Treatment A, B, C and D at Day1 (=day of intake TMC278).
1 secondary outcome
To evaluate the short-term safety and tolerability of co-administration of omeprazole with a single 25mg and 50mg dose of TMC278
Time frame: 13 weeks (this includes a treatment, washout and follow up period and is excluding screening period of maximum 21 days before first medication intake)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibotec Pharmaceuticals Clinical Trial study director
Tibotec Pharmaceutical Limited
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMC278; Omeprazole in people with HIV Infections, run by Tibotec Pharmaceuticals, Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of TMC278 assessed after co-administration of 20mg q.d. omeprazole taken either in the morning (1.5 h before TMC278) or in the evening (12 h before TMC278); assess 24h intragastric pH at days of intake of TMC278 (time frame: Plasma levels: Treatment A, B, C and D: Day1 (at 11 time points), Day2, 3, 4, 6 and 8 (all at 1 time point). Intragastric pH: Treatment A, B, C and D at Day1 (=day of intake TMC278).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2010.